Kornimate/medical-research-clean huggingface dataset:
calcium dobesilate for chronic venous wounds

Conditions: Ulcer

Summary: the objective of the study is to assess the efficacy of calcium dobesilate for treating chronic venous wounds. the hypothesis is that venous ulcers treated with standards measures (compressive measures) and calcium dobesilate will heal-up better than venous ulcers treated with standards measures (compressive measures) and placebo.


Eligibility criteria:
inclusion criteria: * patients with venous ulcer (ceap 6) that affect epidermis, dermis and/or subcutaneous tissue, with and area superior to 3 cm2 * ankle-arm index 0.9 or superior * written informed consent of the patients exclusion criteria: * patients with venous ulcer (ceap 6) that affect bone or with and area inferior to 3 cm2 * ankle-arm index inferior to 0.9 * no written informed consent of the patients * diabetes mellitus i y ii * patients with renal failure and dialysis * vascular surgery needed * impossibility to use compressive measures on the leg * use of topic antibiotics, silver dressing, growth factors, plasma-rich in platelets, skin graft, pentoxifylline, ultrasounds, laser, hyperbaric oxygen, electric stimulation o vacuum. * pregnancy * breast feeding * no anticonceptives measures * allergy or intolerance to phebotonics * background of neutropenia or leucopenia * basal leucocytes \< 3.500/ml

Keywords: venous ulcer phlebotonic calcium dobesilate clinical trial
the effect of intravenous infusion of tramadol-ondansetron on recovery after caesarean section.

Conditions: Post Operative Pain; Cesarean Section; Tramadol; Postoperative Recovery; Quality of Recovery; Ondansetron; QoR-15; ObsQor-10; Postcesarean Recovery

Summary: it will be a prospective observational cohort study. the investigators will compare post-cesarean section recovery in patients receiving intravenous infusion of tramadol-ondansetron versus epidural catheter with infusion of local anesthetics.

the primary outcome is to assess the non-inferiority in terms of post-cesarean section recovery of the intravenous perfusion of tramadol + ondansetron compared to the perfusion of local anesthetics through an epidural catheter. this will be a prospective observational cohort study, with a total n of 312 patients who underwent a cesarean section. 156 who maintain the epidural catheter as the main measure of analgesia for 24 h, and 156 who receive an infusion of tramadol-ondansetron from the end of the cesarean section and for the following 24 h. the following data will be collected at 24 and 48 hours: need for unscheduled pharmacological reinforcement, adverse effects, qor (quality of recovery) score 15, obsqor-10 (obstetric quality of recovery) score, and visual analogue pain scale (vas) every 4 hours for 48 hours. the incidence of chronic pain 90 days after cesarean section will be assessed using the numerical pain rating scale (nrs).

Eligibility criteria:
inclusion criteria: * woman over 18 years old undergoing caesarean section * she agrees to participate voluntarily. * she is already receiving any of the analgesic strategies studied. exclusion criteria: * receiving an analgesic medication other than the one mentioned as "routine multimodal analgesia" (either as regular medication or for acute post-surgical pain) * medical history that determines the baseline data of the scales and data that we collect ( pain or previous disabilities; addiction to drugs, alcohol or drugs; another disease that worsens the quality of life) * medical history that conditions the pharmacological effect (allergy, intolerance or atypical reaction to any of the drugs involved in its treatment or possible cross-reactions ) * contraindication for neuraxial techniques (patient refusal, difficulty in understanding or communication, localized infection, increased intracranial pressure, or other medical criteria) * two or more previous caesarean sections * difficulty in understanding or communication * mother care will not be available to the newborn in the postpartum period for any reason

Keywords: tramadol cesarean section postcesarean section qor-15 obsqor-10 postcesarean recovery
extra virgin olive oil, red wine polyphenols and fecal microbiota

Conditions: Obesity

Summary: in this study, the investigators will evaluate the prebiotic effect of a moderate intake of extra virgin olive oil or red wine on the modulation of gut microbiota composition and the improvement of cardiometabolic factors in obese and lean adults subjects.


Eligibility criteria:
inclusion criteria: * obese patients (body mass index (bmi= or \> 30kg/m2) with high insulin resistance (measured by homeostasis model assessment insulin resistance index (homa-ir) \> 5.5. * lean subjects (bmi\< 28kg/m2) with low insulin resistance (homa-ir\< 3.3). exclusion criteria (all patients): * type 2 diabetes * acute or chronic infection * inflammatory disease or endocrine disorders. * history of cancer. * anti-inflammatory, corticosteroid, hormone, or antibiotic drug treatment * a history of alcohol abuse or drug dependence * a restrictive diet or a weight change ≥5 kg during the 3 months prior to the study. * intake of prebiotics, probiotics, vitamin supplements or any other medical treatment influencing intestinal microbiota during the 3 months before the start of the study or during the study.

Keywords: insulin resistance extra virgin olive oil red wine diet microbiota
adnp syndrome: the seaver autism center for research and treatment is characterizing adnp-related neurodevelopmental disorders using genetic, medical, and neuropsychological measures.

Conditions: ADNP; Helsmoortel-Van Der Aa Syndrome; Autism Spectrum Disorder

Summary: adnp, also known as activity dependent neuroprotective protein, is a rare neurodevelopmental disorder caused by mutations encompassing the adnp gene on chromosome 20. clinically, adnp syndrome is characterized by intellectual disability and global developmental delay. this study seeks to characterize adnp-related neurodevelopmental disorders using a number of genetic, medical and neuropsychological measures.

subjects with a variant in the adnp gene will be asked to complete a battery of developmental, behavioral and medical assessments to better characterize gene-related neurodevelopmental deficits. this series of assessments takes place over the course of a three-day period. it includes the autism diagnostic observation schedule (ados), parent interviews regarding developmental history and behavior, a psychiatric evaluation, a neurology assessment, as well as a clinical genetic evaluation that includes a physical and vitals exam. affected individuals, as well as biologically related siblings, will also undergo a series of sensory assessments, including a research eeg, visual evoked potential, and an eyetracking assessment. family members present for the visit will also be asked to provide a blood and/or saliva sample for research genetics.

Eligibility criteria:
inclusion criteria: * eligible participants must have a documented variant affecting the adnp gene that the research team determines to be likely or definitely pathogenic. * eligible participants must be at least 2 years of age. exclusion criteria: * none

Keywords: adnp intellectual disability autism spectrum disorder global developmental delay neurodevelopmental deficits developmental disability
epidural- evaluation of preexisting information regarding neuroaxial procedures for labour analgesia

Conditions: Neuroaxial Analgesia Procedures

Summary: the aim of this research project is to anonymously survey pregnant patients before the anaesthesiological consultation about their prior knowledge of planned neuroaxial procedures in the context of childbirth by conducting an online survey and to evaluate the sources of that information.

within labour and delivery, neuroaxial anaesthesia (peridural or spinal anaesthesia) is commonly used in accordance with clinical practice guidelines. however, from a professional perspective, there are still questionable and incorrect statements about possible complications and side effects that cannot be justified medically. in an increasingly technological and networked society, the dissemination of medical information via various sources of information poses a potentially serious problem in terms of disinformation, and the correct classification of information is becoming more and more difficult. anaesthesiologists are increasingly confronted with consultations in which, in addition to the actual informed consent for the intervention, extensive clarification of existing contradictory information is required. the aim of this research project is to survey pregnant patients prior to receiving an anaesthesiological consultation about their previous knowledge of the intended procedure by conducting an anonymous online survey.

Eligibility criteria:
inclusion criteria: * pregnant women prior to delivery exclusion criteria: * women under 18 years of age
safety and efficacy of incb007839 with trastuzumab and vinorelbine in patients with metastatic her2+ breast cancer

Conditions: Breast Cancer

Summary: this phase i/ii study is designed to assess the safety and therapeutic effect of incb007839 in combination with trastuzumab and vinorelbine in patients with metastatic her2+ breast cancer.


Eligibility criteria:
inclusion criteria: * subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer * subject with histological her2+ status as determined by fish with a gene amplification score of ≥ 2.2 * subject with availability of archival biopsy tissue from primary tumor or metastatic lesions * subject with presence of measurable disease based on recist 1.1 * subject who has received no more than three prior her2-directed therapeutic regimens for advanced breast cancer exclusion criteria: * subject with left ventricular ejection fraction (lvef) below institutional normal range * subject with metastasis to the central nervous system unless asymptomatic and clinically stable * subject with current active malignancy other than breast cancer * subject with prior history of other malignancy except for cancers from which the patient is currently disease free * subject with significant renal or hepatic dysfunction * subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy * subject with insufficient bone marrow function * subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy. * subject with current active bacterial, hepatitis b or c, and/or hiv infections
the effect of respiratory muscle warm-up on pulmonary diffusion capacity in athletes

Conditions: Healty Male Volunteers; Athlete

Summary: several studies suggest that inspiratory muscle warm-up (imw) could potentially affect exercise performance; however, its mechanistic basis is still unclear. the aim of this study was to examine the effect of imw on lung diffusing capacity for carbon monoxide, cardiorespiratory, perceptual and performance outcomes in elite athletes from different disciplines. the aim of this study is to evaluate the effects of imw on diffusion capacity for carbon monoxide, cardiorespiratory, perceptual and performance outcomes during high-intensity exercise in elite athletes from different disciplines. the study will be conducted using a randomized, placebo-controlled, double-blind and crossover study experimental design involving 35 athletes from various sports disciplines, including endurance, strength, skill-based, and mixed disciplines. participants will attend the laboratory on four separate occasions. during the first visit, they will be informed about the study and familiarized with the application and measurement procedures. in the second visit, a general warm-up will be performed. during the third and fourth visits, imw (imw40% or imw placebo) protocols will be applied in addition to the general warm-up. measurements of dlco, pulmonary function tests, respiratory muscle strength, and gas analysis during maximal aerobic exercise will be collected both before and after the warm-up protocols.

a. study desing this study will employ a placebo-controlled, randomized, crossover, and double-blind research design to evaluate the effects of three warm-up conditions: control, placebo 15%, and imw 40%. athletes will be randomly assigned to the conditions using a crossover approach, ensuring that all participants will experience each protocol on separate days. the warm-up protocols will include: general warm-up (control): a standard warm-up without resistance. imw 40%: a general warm-up combined with respiratory muscle exercise at 40% resistance. placebo 15%: a general warm-up combined with placebo respiratory muscle exercise at 15% resistance. blinding will be maintained for both participants and researchers. participants will be informed that the study aims to investigate various warm-up types, while the true purpose will remain concealed. this design will ensure reliability and minimize bias in the data to be collected.

Eligibility criteria:
inclusion criteria: * age between 18-24 years. * a training history of at least six years. * regular training frequency of at least four sessions per week. exclusion criteria: * history of smoking. * history of physical disability or acute respiratory or cardiovascular disease within the past three months. * diagnosis of sars-cov-2 within the past three months. * pulmonary function measurements outside the normal clinical range (≤ 80%).

Keywords: inspiratory muscle warm-up warm-up dlco
decalcification of the aortic valve by vitamin k2 (menaquinone-7)

Conditions: Aortic Valve Disease

Summary: aortic stenosis is a common but fatal disease when it becomes symptomatic, specially if not treated. until now surgery remains the only reliable and effective treatment. in this study, the investigators will examine the effect of high dose of menaquinone-7 (mk-7) supplementation (1000 mcg)/day on the progression of the aortic valve disease. the investigators hypothesize that mk-7 supplementation may slow or even reverse the progression of the disease process.

the study is a randomized clinical trial that will use cardiac echography and multi-detector computed tomography to compare the changes in the aortic valve calcification score (avcs) over 3 years when using: 1. 1000 mcg/d vitamin k2 (menaquinone-7) + 5000 iu/d vitamin d3 2. 5000 iu/d vitamin d3 as a control group

Eligibility criteria:
inclusion criteria: * avcs \> 300 without aortic valve stenosis requiring operation * focus on patients with: 1. bicuspid aortic valve 2. dialysis or ckd 3. statin treatment exclusion criteria: * use of vitamin k antagonist * malabsorption problem * lvef \< 40% * a life expectancy \< 3 years

Keywords: avd
controlled study of chain blanket for insomnia

Conditions: Insomnia

Summary: the aim of the study is to compare an intervention with a weighted metal chain blanket of 8 kg with a control plastic chain blanket of 1,5 kg for patients with major depressive disorder, bipolar disorder, generalized anxiety disorder (gad) and/or attention deficit hyperactivity disorder (adhd) and co-occurring insomnia. patients are evaluated by a rater blind to treatment allocation with insomnia severity index (isi), fatigue symptom inventory (fsi), hospital anxiety and depression scale (had) and actigraphy before, during and at primary end-point after 4 weeks use of the blanket.

insomnia is a common and problematic symptom in many psychiatric disorders. the aim of this study is to evaluate the effect of weighted chain blankets on insomnia and other sleep-related symptoms for patients with major depressive disorder, bipolar disorder, generalized anxiety disorder (gad) and/or adhd. potential participants are asked to participate in a study comparing two different types of chain blankets, not mentioning the difference in weight. after signing a informed consent, participants were randomly assigned on a 50/50 basis to a weighted blanket containing metal chains weighing 8 kg or a control blanket containing plastic chains weighing 1,5 kg. insomnia severity is assessed before and weekly until endpoint at four weeks use of the blanket by a rater blind to treatment allocation. participants sleep will also be monitored by actigraphy. the controlled phase of the study is followed by a one year open follow up study where all participants are offered to use a weighted blanket of any type.

Eligibility criteria:
inclusion criteria: • clinical insomnia for more than two months with a score over 14 points at the insomnia severity index (isi)1 and a diagnosis of either major depressive disorder, bipolar disorder, generalized anxiety disorder (gad) or adhd. exclusion criteria: * active drug abuse, * overuse of sleep medication, * illness affecting cognitive functions, such as dementia, schizophrenia, developmental disorders, parkinson's disease or an acquired brain injury.
mobilization with movement in patients with osteoarthritis of the hip

Conditions: Osteoarthritis Hip; Joint Disease; Musculoskeletal Diseases; Pathologic Processes

Summary: the concept of mobilization with movement, also referred to as a mulligan mobilization, has not been studied in patients with hip osteoarthritis, subsisting questions about the possible effects in this population. the aim of this randomized controlled study is to compare the immediate effects of mulligan mobilization with movement technique of pain, range of motion and physical function in patients with osteoarthritis of the hip.

mulligan original theory for the efficacy of a mobilization with movement (mwm) is based on the concept associated with a "positional joint failure," which occurs due to injury and may lead to a change in the joint alignment and hence its biomechanical resulting in symptoms such as pain, joint stiffness or weakness. to perform the mwm technique it is required to implement many criteria. during execution is applied an maintained accessory glide in order to correct the positional fault, while a physiological movement or action that usually caused the pain is performed actively or passively. a key component for the mwm is that pain should always be reduced and / or eliminated during application. all study participants will be submitted to an initial assessment protocol to determine the intensity of pain, the range of motion (rom) in flexion and internal rotation of the hip and the collection of physical function parameters. after that, the intervention will be performed for each group, and then the re-evaluation will be carried out (final evaluation), pain intensity, rom and physical function tests..

Eligibility criteria:
inclusion criteria: clinical criteria for the diagnosis of osteoarthritis of the hip (sensitivity 86% and specificity 75%) are: * medial hip rotation ≥15º, pain during medial rotation of the hip, morning fatigue in hip\> 60 minutes and older than 50 years or * medial hip rotation \<15, hip flexion ≤ 115 exclusion criteria: * previous surgery or hip replacement or knee joint * another surgery in the lower extremities performed within 6 months, rheumatoid arthritis * uncontrolled hypertension or risk (moderate - high) of cardiac complications during exercise * disability unrelated to the hip or knee to prevent the safe participation during exercise, appliance of manual therapy or during march: vision problems affecting mobility, body weight equal to or greater than 155 kg, primary neurogenic disorder or significantly limitation of the lumbar level,advanced osteoporosis with manual therapy or other treatment technique that may interfere with the study * with inability to understand the instructions and complete the study assessments

Keywords: osteoarthritis of the hip pain range of motion physical function manual therapy
investigation of non-ce marked intermittent catheters.

Conditions: Retention, Urinary

Summary: investigation of novel non-ce marked intermittent catheters. the study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter

the cp323 study investigated a novel non-ce marked intermittent catheter, designed in two different variants, variant 1 and variant 2, respectively, and was conducted in denmark. the study was a randomized, single blinded, cross-over investigation, comparing the two new variant catheters with a comparator catheter in 15 male ic users. for each participant, the study thus contains three test visits/treatment arms (comparator, variant 1 and variant 2, respectively), to which the 15 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). there were 4-14 days between the test visits.

Eligibility criteria:
inclusion criteria: * male * minimum 18 years of age and with full legal capacity * daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months * ability to self-catheterize * written informed consent, signed letter of authority and signed secrecy agreement given exclusion criteria: * participation in any other clinical study during this investigation * symptoms of urinary tract infection as judged by the investigator * any know allergies towards ingredients in the products * relevant medical history that would prevent the subject from participation in the investigation (investigators judgement)
extracorporeal filtration of subarachnoid hemorrhage via spinal catheter

Conditions: Subarachnoid Hemorrhage

Summary: the objective of this feasibility study is to demonstrate the safety and feasibility of using an investigational extracorporeal system and catheter to filter hemorrhagic cerebrospinal fluid (csf) post subarachnoid hemorrhage (sah) treatment, and reintroduce the csf via the same catheter.


Eligibility criteria:
inclusion criteria: * age: 18 years or older * informed consent by the patient or his/her legally authorized representative * modified fisher grade 2, 3, or 4 * hunt \& hess i-iii * first aneurysmal sah that has been confirmed by angio, cta or mra * patient is ≤ 48 hours post bleeding event * world federation of neurosurgeons (wfns) grades i-iv and those grade v patients who improve to grade iv or less after ventriculostomy. exclusion criteria: * patients with a sah due to mycotic aneurysm or av malformation * patients who present with an acute mi or unstable angina * patients with uncontrolled diabetes * patients who present with a creatinine \> 2.0mg/dl * imaging demonstrates supratentorial mass lesions greater than 50 cc * imaging demonstrates more than 5 mm of mid-line-shift associated with infarction and or edema * effacement of the basilar cisterns (suprasellar, ambient, chiasmatic and quadrageminal) * vasospasm on admission as defined by angiographic evidence * patients with a coagulopathy that cannot be reversed per the professional discretion of the investigator * thrombocytopenia def. platelet count \< 100,000 * patients on low molecular weight heparin e.g., lovenox * patients on clopidogrel bisulfate (plavix) or other chronic platelet inhibitors * patients with a documented history of cirrhosis * patients who will be managed with supportive care rather than intervention * obstructive hydrocephalus i.e., non-communicating * pregnancy * history of posterior fusion hardware that would interfere with placement of the catheter * pre-existing lumbar drain * local skin infections or eruptions over the puncture site * signs of systemic infection/sepsis or pneumonia * lumbar puncture within 6 hours * concurrent participation in another study which is not observational or retrospective in nature without prior approval from the sponsor